Everolimus Therapy in People With Birt-Hogg-Dube Syndrome (BHD)-Associated Kidney Cancer or Sporadic Chromophobe Renal Cancer

Summary

Background: \- Research has shown that the drug everolimus can stop cancer cells from growing. It is approved for people with advanced kidney cancer. Researchers want to see if it also helps people with two other types of kidney cancer. Objective: \- To see if everolimus is safe and effective in people with Birt-Hogg-Dube Syndrome (BHD)-associated kidney cancer or sporadic (nonfamilial) chromophobe renal cancer. Eligibility: \- People ages 18 and over with BHD-associated kidney cancer or advanced sporadic chromophobe renal cancer. Design: * Participants will be screened with: * Medical history, physical exam, and blood and urine tests. * Computed tomography (CT) scan or magnetic resonance imaging (MRI) scan. They will lie in a machine that takes pictures of their chest/abdomen/pelvis. * They may also be screened with: * Another scan, of the brain or neck. * Bone scan. * Positron emission tomography scan with fludeoxyglucose (FDG-PET). * Heart and lung tests. * Tests for hepatitis. * Participants will take a tablet once a day by mouth for up to a year. They will keep a diary of when they take the tablet and any symptoms. * During the study, participants will have physical exams and urine and blood tests. They will have scans of the chest/abdomen/pelvis. They may have FDG-PET and bone scans. * Participants will have tests for hepatitis and may have a tumor sample taken. * Participants will have a follow-up visit 4-5 weeks finishing taking the drug. They will have a physical exam and blood tests. They may have scans and/or hepatitis tests. * Participants will be called about every 3-6 months after the study ends to see how they are doing

Timeline

Start

2015-07-21

Primary completion

2018-04-17

Completion

2018-04-17

Outcome

Outcome not reported

Stopped (Enrollment): “Study was terminated due to slow, insufficient accrual.”

Publications

• Background Schmidt LS. Birt-Hogg-Dube syndrome: from gene discovery to molecularly targeted therapies. Fam Cancer. 2013 Sep;12(3):357-64. doi: 10.1007/s10689-012-9574-y.
• Background Birt AR, Hogg GR, Dube WJ. Hereditary multiple fibrofolliculomas with trichodiscomas and acrochordons. Arch Dermatol. 1977 Dec;113(12):1674-7.
• Background Schmidt LS, Warren MB, Nickerson ML, Weirich G, Matrosova V, Toro JR, Turner ML, Duray P, Merino M, Hewitt S, Pavlovich CP, Glenn G, Greenberg CR, Linehan WM, Zbar B. Birt-Hogg-Dube syndrome, a genodermatosis associated with spontaneous pneumothorax and kidney neoplasia, maps to chromosome 17p11.2. Am J Hum Genet. 2001 Oct;69(4):876-82. doi: 10.1086/323744. Epub 2001 Aug 30.

Drugs

Indications